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MLN0002 Trial -AKA- Vedolizumab

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Ulcerative Colitis
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Posted 1/18/2010 10:22 AM (GMT 0)
I am on the vedo trial in Australia, just had my first infusion last week. Have been slightly better but not a remarkable improvement yet, so not sure if I'm getting active drug or placebo yet.

Dr. A, i understand that after a long time of being on the drug rollercoaster that people will do anything to get better, but misreporting your symptoms in order to manipulate if you receive the active drug or placebo, surely that's going to stuff up the results of the trial?
Posted 1/18/2010 11:23 AM (GMT 0)
DR-A/uc-mom

When deciding to go onto the trial, I did read through all the possible drug/placebo options and I also noticed the strange 6 week "non-responders" to get the active drug automatically. But, everyone else has a 1 in 3 chance of getting placebo - even if you have the worst med-resistant UC in the world and you have responded - you could find yourself landed into the placebo group, which would be terrible.  But, I recognise, thats the whole point of placebo-controlled trials.

Anyway, getting back to your point about mis-reporting symptoms, I don't think you can really.  You have a flex sig at week 6 and it is the results of that that determine what happens next.

Yes, you have to complete the daily symptom diary but that does not carry much weight when it comes to them calculating your mayo score compared to the scopes. At least thats what happened to me at the start of the trial.

Best wishes

Posted 1/18/2010 4:45 PM (GMT 0)
From what you guys are saying the golimumab hasn't worked to well what about the 6 mp I need to make a choice about what to try next and I want to be very athletic any advice?
Posted 2/4/2010 11:00 AM (GMT 0)
I have just been taken off the trial as I now have a rash on my face (rosacea)
Posted 2/4/2010 11:45 AM (GMT 0)
Oh no. I am sorry to hear that cfg.

Does that mean you cannot go back onto it?  Hope your feeling better.

Posted 3/11/2010 7:55 PM (GMT 0)
Bump - I was initially told that the trail being done where I live was for Remicade, but after being contacted last night, I now know that it it is for Vedolizumab. I printed out the consent forms today but have yet to read them - has anyone taking part in this trial had success?
Posted 3/12/2010 10:23 AM (GMT 0)
Hi Lookingforhealing

Funny I came across your post today as I was just about to post an update.

I have been on the MLN0002 trial since January 2010.  I am now in the maintenance phase, as I did respond to the drug in the introduction phase.

I am doing fairly well.  At Week 0 my colonoscopy showed moderate inflammation, my scope at week 6 showed mild.  So, not in remission, but an improvement.

Of course, I could be on placebo, but I was definately on the real drug in phase 1, we will have to see how things go in this phase.

You will almost certainly be put on open-label as the placebo numbers are now full.  Lucky you!

Hope it works for you.

Best wishes

Posted 3/15/2010 7:50 AM (GMT 0)
I have just come home from hospital after a severe flare and had an infliximab (remicade) infusion ...the next one is in 2 weeks....im completely exhausted..is this normal
Posted 3/16/2010 5:00 PM (GMT 0)
@barnsbury - Did you have any side effects from the drug? Also, how was calling in everyday?
Posted 5/29/2010 1:44 PM (GMT 0)
x5800 - Ooops, sorry, I've just realised 2 months on that I didnt reply to your question.....

I have had very few side effects.  Little nausea, some tiredness and mild neck pain.  Nothing major.  As to calling in everyday - I HATE it.  It is a real pain.  Some days I forgot, but then you have to backdate to the previous day and they also notify the hospital, who in turn remind me to get phoning!  I wish it was a written diary..

Are you on the trial?

 

Posted 1/16/2012 3:34 AM (GMT 0)
Have been diag. w/ UC since Sept 2006.

Tried several other drugs / doctors with poor - marginal results.

I am at week 128 in this study, on open label getting IV every 4 weeks, Vedolizumab.

I started about April 2009. I went into remission August 2010. 3 stools a day, formed, no blood. No side effects. No steroids. Regained most of strength and stamina. Asacol 2.4g per day.

Now I appear to be starting to flare. Big "D" 5-7 times a day, urgent, bleeding, exhausted. Nasal allergies bad, head cold, diet out of control, weight gain 25lbs, job, and personal life stress at an all time high.

I think if I had stayed on the straight and narrow I would stil be good. Starting today to get back there.  

Posted 7/4/2012 9:02 AM (GMT 0)
hello bigfatbaby, uc_mum, barnsbury and lookingforhealing - how are you doing now on the vedolizumab? Does it have you in remission?
Posted 7/4/2012 9:03 AM (GMT 0)
also bigfatbaby, what do you mean if you "had stayed on the straight and narrow I would still be good?"
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